Idiopathic Thrombocytopenic Purpura
Conditions
Brief summary
This single arm study will evaluate the efficacy and safety of MabThera monotherapy in patients with refractory, relapsing or chronic idiopathic thrombocytopenic purpura (ITP). Patients will receive infusions of MabThera 1000mg i.v. on days 1 and 15. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Interventions
DRUGrituximab [MabThera/Rituxan]
1000mg iv on days 1 and 15
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients, \>=18 years of age; * refractory, relapsing or chronic idiopathic thrombocytopenic purpura; * stable therapy during 3 weeks prior to study entry.
Exclusion criteria
* newly diagnosed ITP (\<6 weeks); * prior treatment with MabThera; * active bleeding requiring platelet transfusion within 7 days prior to entry into study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a Complete Hematological Response (CR) or Confirmed Partial Hematological Response (PR) | Week 8 | Percentage of participants with an overall response at Week 8 achieving a CR or PR as evaluated by platelets, new or increased Idiopathic Thrombocytopenic Purpura (ITP)-related treatments and corticosteroids given for Adverse Events (AEs). CR was defined as a platelet count of greater than (\>) 150x10\^9/ liters (L) over at least 2 consecutive measurements at least 2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. PR was defined as platelet count of \>50x10\^9/L over at least 2 consecutive measurements at least \<2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. Overall response rate (participants who achieved CR or confirmed PR) was evaluated using platelets, new or increased ITP related treatments, and corticosteroids given for AEs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved CR | Week 52 | CR was defined as platelet counts \>150x10\^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. |
| Time to CR | Baseline to Week 52 | Time to CR was defined as the time from the first infusion to the first date on which CR was achieved. CR was defined as platelet counts \>150x10\^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. Participants without an event were censored at the date of last assessment. |
| Percentage of Participants Who Achieved PR | Week 52 | PR was defined as platelet counts \>50x10\^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. |
| Time to PR | Baseline to Week 52 | Time to response was defined as the time from the first infusion to the first date on which PR was achieved. PR was defined as platelet counts \> 50x10\^9/L over ≥ 2 consecutive measurements ≥ 2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. |
| Percentage of Participants Who Achieved MR | Week 52 | MR was defined as participants registered with chronic ITP with a platelet count of \>30x10\^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50 to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. |
| Time to MR | Baseline to Week 52 | Time to response was defined as the time from the first infusion to the first date on which MR was achieved. MR was defined as participants registered with chronic ITP with a platelet count of \>30x10\^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50 percent (%) to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. |
| Percentage of Participants With Continued CR From Week 8 to Week 52 | Week 8 to Week 52 | The number of participants with a durable CR assessed in CR responders whose responses were sustained from Week 8 through to the end of the study or withdrawal, irrespective of change of treatment. CR was defined as platelet counts \>150x10\^9/L over ≥2 consecutive measurements ≥ 2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. |
| Duration of CR in Participants With Continued CR From Week 8 Until Week 52 | Week 8 to Week 52 | Duration of response was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of CR, irrespective of change of treatment. CR was defined as platelet counts \>150x10\^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. |
| Percentage of Participants With Hematological CR, PR, or Minor Response (MR) | Week 8 | Percentage of participants with CR, PR, and MR at Week 8 as evaluated by platelet count where CR is greater than or equal to (≥)150x10\^9/L, PR ≥ 50x10\^9/L, MR equals (=) 30x10\^9/L over 2 consecutive measurements at least 2 weeks apart but no more than 60 days apart with no increase in concomitant therapy or initiation of new ITP therapy. |
| Duration of MR in Participants With Continued MR From Week 8 Until Week 52 | Week 8 to Week 52 | Duration of response was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of MR, irrespective of change of treatment. MR was defined as participants registered with ITP in relapse with a platelet count of \> 30x10\^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. Participants registered with chronic ITP with a platelet count of \>30x10\^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50% to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. |
| Time to Inititiation of New ITP Therapy - Percentage of Participants With an Event | Week 52 | Percentage of participants with an event of initiation of new ITP therapy and/or increase in dose of existing ITP therapy, including date on which decision made in relation to splenectomy, from time of first treatment to Week 52. |
| Time to Initiation of New ITP Therapy | Baseline to Week 52 | Median time in days to initiation of new ITP therapy and/or increase in dose of existing ITP therapy, including date on which decision made in relation to splenectomy, from time of first treatment to Week 52. |
| Percentage of Therapeutic Responders | Week 26 and Week 52 | Percentage of participants with a therapeutic response, defined as achieving CR, PR, or MR assessed at Week 26 and Week 52 or hematological response, defined as achieving CR, PR, or MR at Week 8. CR was defined as no platelet response or no reduction in the dose intensity of concomitant ITP therapy compared with that at screening. PR response was defined as at least a minor platelet response that enabled a 50% to 99% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. MR was defined as at least a minor platelet response that enabled a 1% to 49% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. |
| Percentage of Participants With a Therapeutic Response | Week 26 and Week 52 | Number of therapeutic responder participants by CR, PR, MR, or no response (NR) measured at Week 26 and Week 52. CR was defined as no platelet response or no reduction in the dose intensity of concomitant ITP therapy compared with that at screening. PR was defined as at least minor platelet response that enabled a 50% to 99% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. MR was defined as at least minor platelet response that enabled a 1% to 49% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. |
| Cluster of Differentiation 19 (CD19) B Cell Count | Baseline, Weeks 1, 3, and 8, Follow-up Months 4, 6, 8, 10, and 12, and Last Day | Value of mean CD19+ B cell count at baseline. The standard reference range for CD19 is 0.05 to 0.35 x10\^9/L. |
| Change From Baseline in CD19 B Cell Count | Weeks 3, 8 and Months 4, 6, 8, 10 and 12, and last day | Actual values of CD19+ mean B cell count assessed at Weeks 3 and 8, and Months 4, 6, 8, 10 and 12, and last day. The standard reference range for CD19 is 0.05 to 0.35 x10\^9/L. |
| Duration of PR in Participants With Continued PR From Week 8 Until Week 52 | Week 8 to Week 52 | Duration of PR was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of PR, irrespective of change of treatment. PR was defined as platelet counts \>50x10\^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rituximab Participants received rituximab 1000 mg IV on Days 1 and 15. | 122 |
| Total | 122 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Death | 1 |
| Overall Study | Lack of Efficacy | 8 |
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Protocol Violation | 5 |
| Overall Study | Reason not specified | 1 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Rituximab |
|---|---|
| Age, Continuous | 49.5 years STANDARD_DEVIATION 18.59 |
| Sex: Female, Male Female | 70 Participants |
| Sex: Female, Male Male | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 62 / 122 |
| serious Total, serious adverse events | 12 / 122 |
Outcome results
Primary
Percentage of Participants Achieving a Complete Hematological Response (CR) or Confirmed Partial Hematological Response (PR)
Percentage of participants with an overall response at Week 8 achieving a CR or PR as evaluated by platelets, new or increased Idiopathic Thrombocytopenic Purpura (ITP)-related treatments and corticosteroids given for Adverse Events (AEs). CR was defined as a platelet count of greater than (\>) 150x10\^9/ liters (L) over at least 2 consecutive measurements at least 2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. PR was defined as platelet count of \>50x10\^9/L over at least 2 consecutive measurements at least \<2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. Overall response rate (participants who achieved CR or confirmed PR) was evaluated using platelets, new or increased ITP related treatments, and corticosteroids given for AEs.
Time frame: Week 8
Population: Intent-to-Treat Replaced (ITTR) Population: participants who received at least 1 dose of study medication, excluded those lost to follow-up before completing treatment (reasons other than disease progression/toxicity) and/or those without documented platelet count of less than or equal to (≤)50x10\^9/L within 7 days prior to 1st rituximab infusion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab 1000 mg | Percentage of Participants Achieving a Complete Hematological Response (CR) or Confirmed Partial Hematological Response (PR) | 43.5 percentage of participants |
Secondary
Change From Baseline in CD19 B Cell Count
Actual values of CD19+ mean B cell count assessed at Weeks 3 and 8, and Months 4, 6, 8, 10 and 12, and last day. The standard reference range for CD19 is 0.05 to 0.35 x10\^9/L.
Time frame: Weeks 3, 8 and Months 4, 6, 8, 10 and 12, and last day
Population: Safety Analysis Population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab 1000 mg | Change From Baseline in CD19 B Cell Count | Follow-up Month 6 (n=63) | -0.23 10^9 cells/L | Standard Deviation 0.367 |
| Rituximab 1000 mg | Change From Baseline in CD19 B Cell Count | Follow-up Month 8 (n=44) | -0.22 10^9 cells/L | Standard Deviation 0.412 |
| Rituximab 1000 mg | Change From Baseline in CD19 B Cell Count | Week 3 (n=81) | -0.23 10^9 cells/L | Standard Deviation 0.29 |
| Rituximab 1000 mg | Change From Baseline in CD19 B Cell Count | Week 8 (n=75) | -0.27 10^9 cells/L | Standard Deviation 0.393 |
| Rituximab 1000 mg | Change From Baseline in CD19 B Cell Count | Follow-up Month 4 (n=47) | -0.21 10^9 cells/L | Standard Deviation 0.217 |
| Rituximab 1000 mg | Change From Baseline in CD19 B Cell Count | Follow-up Month 10 (n=39) | -0.08 10^9 cells/L | Standard Deviation 0.207 |
| Rituximab 1000 mg | Change From Baseline in CD19 B Cell Count | Follow-up Month 12 (n=55) | -0.06 10^9 cells/L | Standard Deviation 0.409 |
| Rituximab 1000 mg | Change From Baseline in CD19 B Cell Count | Last Day (n=84) | -0.13 10^9 cells/L | Standard Deviation 0.389 |
Secondary
Cluster of Differentiation 19 (CD19) B Cell Count
Value of mean CD19+ B cell count at baseline. The standard reference range for CD19 is 0.05 to 0.35 x10\^9/L.
Time frame: Baseline, Weeks 1, 3, and 8, Follow-up Months 4, 6, 8, 10, and 12, and Last Day
Population: Safety Analysis Population; n (number) = number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab 1000 mg | Cluster of Differentiation 19 (CD19) B Cell Count | Follow-up Month 12 (n=70) | 0.18 10^9 cells/L | Standard Deviation 0.289 |
| Rituximab 1000 mg | Cluster of Differentiation 19 (CD19) B Cell Count | Last Day (n=101) | 0.13 10^9 cells/L | Standard Deviation 0.252 |
| Rituximab 1000 mg | Cluster of Differentiation 19 (CD19) B Cell Count | Baseline (n=84) | 0.27 10^9 cells/L | Standard Deviation 0.374 |
| Rituximab 1000 mg | Cluster of Differentiation 19 (CD19) B Cell Count | Week 1 (n=3) | 0.30 10^9 cells/L | Standard Deviation 0.251 |
| Rituximab 1000 mg | Cluster of Differentiation 19 (CD19) B Cell Count | Week 3 (n=96) | 0.01 10^9 cells/L | Standard Deviation 0.052 |
| Rituximab 1000 mg | Cluster of Differentiation 19 (CD19) B Cell Count | Week 8 (n=89) | 0.01 10^9 cells/L | Standard Deviation 0.033 |
| Rituximab 1000 mg | Cluster of Differentiation 19 (CD19) B Cell Count | Follow-up Month 4 (n=57) | 0.01 10^9 cells/L | Standard Deviation 0.029 |
| Rituximab 1000 mg | Cluster of Differentiation 19 (CD19) B Cell Count | Follow-up Month 6 (n=79) | 0.03 10^9 cells/L | Standard Deviation 0.041 |
| Rituximab 1000 mg | Cluster of Differentiation 19 (CD19) B Cell Count | Follow-up Month 8 (n=57) | 0.07 10^9 cells/L | Standard Deviation 0.085 |
| Rituximab 1000 mg | Cluster of Differentiation 19 (CD19) B Cell Count | Follow-up Month 10 (n=48) | 0.15 10^9 cells/L | Standard Deviation 0.315 |
Secondary
Duration of CR in Participants With Continued CR From Week 8 Until Week 52
Duration of response was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of CR, irrespective of change of treatment. CR was defined as platelet counts \>150x10\^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
Time frame: Week 8 to Week 52
Population: ITTR Population; only participants with a CR at Week 8 were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rituximab 1000 mg | Duration of CR in Participants With Continued CR From Week 8 Until Week 52 | NA days |
Secondary
Duration of MR in Participants With Continued MR From Week 8 Until Week 52
Duration of response was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of MR, irrespective of change of treatment. MR was defined as participants registered with ITP in relapse with a platelet count of \> 30x10\^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. Participants registered with chronic ITP with a platelet count of \>30x10\^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50% to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
Time frame: Week 8 to Week 52
Population: ITTR Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rituximab 1000 mg | Duration of MR in Participants With Continued MR From Week 8 Until Week 52 | 256.0 days |
Secondary
Duration of PR in Participants With Continued PR From Week 8 Until Week 52
Duration of PR was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of PR, irrespective of change of treatment. PR was defined as platelet counts \>50x10\^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy.
Time frame: Week 8 to Week 52
Population: ITTR Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rituximab 1000 mg | Duration of PR in Participants With Continued PR From Week 8 Until Week 52 | 247.0 days |
Secondary
Percentage of Participants Who Achieved CR
CR was defined as platelet counts \>150x10\^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
Time frame: Week 52
Population: ITTR Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab 1000 mg | Percentage of Participants Who Achieved CR | 27.8 percentage of participants |
Secondary
Percentage of Participants Who Achieved MR
MR was defined as participants registered with chronic ITP with a platelet count of \>30x10\^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50 to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
Time frame: Week 52
Population: ITTR Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab 1000 mg | Percentage of Participants Who Achieved MR | 71.3 percentage of participants |
Secondary
Percentage of Participants Who Achieved PR
PR was defined as platelet counts \>50x10\^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy.
Time frame: Week 52
Population: ITTR Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab 1000 mg | Percentage of Participants Who Achieved PR | 56.5 percentage of participants |
Secondary
Percentage of Participants With a Therapeutic Response
Number of therapeutic responder participants by CR, PR, MR, or no response (NR) measured at Week 26 and Week 52. CR was defined as no platelet response or no reduction in the dose intensity of concomitant ITP therapy compared with that at screening. PR was defined as at least minor platelet response that enabled a 50% to 99% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. MR was defined as at least minor platelet response that enabled a 1% to 49% reduction in the dose intensity of concomitant ITP therapy compared with that at screening.
Time frame: Week 26 and Week 52
Population: ITTR Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab 1000 mg | Percentage of Participants With a Therapeutic Response | Week 26: CR | 38.0 percentage participants |
| Rituximab 1000 mg | Percentage of Participants With a Therapeutic Response | Week 26: PR | 5.6 percentage participants |
| Rituximab 1000 mg | Percentage of Participants With a Therapeutic Response | Week 26: MR | 0.0 percentage participants |
| Rituximab 1000 mg | Percentage of Participants With a Therapeutic Response | Week 26: NR | 56.5 percentage participants |
| Rituximab 1000 mg | Percentage of Participants With a Therapeutic Response | Week 52: CR | 35.2 percentage participants |
| Rituximab 1000 mg | Percentage of Participants With a Therapeutic Response | Week 52: PR | 0.0 percentage participants |
| Rituximab 1000 mg | Percentage of Participants With a Therapeutic Response | Week 52: MR | 0.0 percentage participants |
| Rituximab 1000 mg | Percentage of Participants With a Therapeutic Response | Week 52: NR | 64.8 percentage participants |
Secondary
Percentage of Participants With Continued CR From Week 8 to Week 52
The number of participants with a durable CR assessed in CR responders whose responses were sustained from Week 8 through to the end of the study or withdrawal, irrespective of change of treatment. CR was defined as platelet counts \>150x10\^9/L over ≥2 consecutive measurements ≥ 2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
Time frame: Week 8 to Week 52
Population: ITTR Population; only participants with a CR at Week 8 were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab 1000 mg | Percentage of Participants With Continued CR From Week 8 to Week 52 | 10 percentage of participants |
Secondary
Percentage of Participants With Hematological CR, PR, or Minor Response (MR)
Percentage of participants with CR, PR, and MR at Week 8 as evaluated by platelet count where CR is greater than or equal to (≥)150x10\^9/L, PR ≥ 50x10\^9/L, MR equals (=) 30x10\^9/L over 2 consecutive measurements at least 2 weeks apart but no more than 60 days apart with no increase in concomitant therapy or initiation of new ITP therapy.
Time frame: Week 8
Population: ITTR Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab 1000 mg | Percentage of Participants With Hematological CR, PR, or Minor Response (MR) | CR | 9.3 percentage of participants |
| Rituximab 1000 mg | Percentage of Participants With Hematological CR, PR, or Minor Response (MR) | PR | 34.3 percentage of participants |
| Rituximab 1000 mg | Percentage of Participants With Hematological CR, PR, or Minor Response (MR) | MR | 17.6 percentage of participants |
Secondary
Percentage of Therapeutic Responders
Percentage of participants with a therapeutic response, defined as achieving CR, PR, or MR assessed at Week 26 and Week 52 or hematological response, defined as achieving CR, PR, or MR at Week 8. CR was defined as no platelet response or no reduction in the dose intensity of concomitant ITP therapy compared with that at screening. PR response was defined as at least a minor platelet response that enabled a 50% to 99% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. MR was defined as at least a minor platelet response that enabled a 1% to 49% reduction in the dose intensity of concomitant ITP therapy compared with that at screening.
Time frame: Week 26 and Week 52
Population: ITTR Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab 1000 mg | Percentage of Therapeutic Responders | Week 26 | 43.5 percentage of participants |
| Rituximab 1000 mg | Percentage of Therapeutic Responders | Week 52 | 35.2 percentage of participants |
Secondary
Time to CR
Time to CR was defined as the time from the first infusion to the first date on which CR was achieved. CR was defined as platelet counts \>150x10\^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. Participants without an event were censored at the date of last assessment.
Time frame: Baseline to Week 52
Population: ITTR Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rituximab 1000 mg | Time to CR | NA days |
Secondary
Time to Initiation of New ITP Therapy
Median time in days to initiation of new ITP therapy and/or increase in dose of existing ITP therapy, including date on which decision made in relation to splenectomy, from time of first treatment to Week 52.
Time frame: Baseline to Week 52
Population: ITTR Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rituximab 1000 mg | Time to Initiation of New ITP Therapy | 314.0 days |
Secondary
Time to Inititiation of New ITP Therapy - Percentage of Participants With an Event
Percentage of participants with an event of initiation of new ITP therapy and/or increase in dose of existing ITP therapy, including date on which decision made in relation to splenectomy, from time of first treatment to Week 52.
Time frame: Week 52
Population: ITTR Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab 1000 mg | Time to Inititiation of New ITP Therapy - Percentage of Participants With an Event | 50.0 percentage of participants |
Secondary
Time to MR
Time to response was defined as the time from the first infusion to the first date on which MR was achieved. MR was defined as participants registered with chronic ITP with a platelet count of \>30x10\^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50 percent (%) to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
Time frame: Baseline to Week 52
Population: ITTR Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rituximab 1000 mg | Time to MR | 22.0 days |
Secondary
Time to PR
Time to response was defined as the time from the first infusion to the first date on which PR was achieved. PR was defined as platelet counts \> 50x10\^9/L over ≥ 2 consecutive measurements ≥ 2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy.
Time frame: Baseline to Week 52
Population: ITTR Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rituximab 1000 mg | Time to PR | 53.0 days |